1. Field of the Invention
This invention relates generally to a spinal implant device for implantation into the intervertebral space between adjacent vertebral bones to potentiate fusion, and more particularly to an implantable device having superior stability provided by polyaxial locking interference screws.
2. Description of the Prior Art
The bones and connective tissue of an adult human spinal column consists of more than twenty discrete bones coupled sequentially to one another by a tri-joint complex which consists of an anterior disc and the two posterior facet joints, the anterior discs of adjacent bones being cushioned by cartilage spacers referred to as intervertebral discs. These more than twenty bones are anatomically categorized as being members of one of four classifications: cervical; thoracic; lumbar; or sacral.
Genetic or developmental irregularities, trauma, chronic stress, tumors, and degenerative wear are a few of the causes that can result in spinal pathologies for which surgical intervention may be necessary. A variety of systems have been disclosed in the art which achieve immobilization and/or fusion of adjacent bones by implanting artificial assemblies in or on the spinal column. The region of the back which needs to be immobilized, as well as the individual variations in anatomy, determine the appropriate surgical protocol and implantation assembly. With respect to the failure of the intervertebral disc, and the insertion of implants and/or height restorative devices, several methods and devices have been disclosed in the prior art.
More particularly, and with respect to the historical development of the present surgical methods and instrumentations, the description of the relevant medical techniques are now described. Failure of the intervertebral disc cartilage generally includes a loss of proper anatomical spacing between the end plates of the opposing vertebral bodies. This loss of height may simply destabilize the spine, or, in severe cases, it may cause considerable neurological impairment as the nerve roots are compressed by the converging lateral extensions of the bones (e.g. in the facet joint).
Restoring the appropriate height to the intervertebral space is the first step in the surgical strategy for correcting this condition. Once this is achieved, one class of surgical implantation procedures involves positioning a device into the intervening space. This may be done through a posterior approach, a lateral approach, or an anterior approach. Various implant devices for this purpose include femoral ring allograft, cylindrical metallic devices (i.e., cages), and metal mesh structures that may be filled with suitable bone graft materials. Some of these implant devices are only suitable for one direction of approach to the spine. All of these devices, however, are provided with the intention that the adjacent bones will, once restored to their appropriate separation, then grow together across the space and fuse together (or at least fuse into the device implanted between the bones).
Most recently, the development of non-fusion implant devices, which purport to permit continued natural movement in the tri-joint complex have provided great promise. The instrumentation and methods for the implantation of these non-fusion devices, as well as the implantation of the fusion devices catalogued previously, therefore should integrate the functions of restoring proper anatomical spacing and easy insertion of the selected device into the formed volume.
To these ends, several instruments for such implantation have been described in the prior art. These include U.S. Pat. No. 6,159,215 to Urbahns, et al., U.S. Pat. No. 6,042,582 to Ray, and U.S. Pat. 5,431,658 to Moskovich. More particularly, the U.S. Patent to Ray describes a device and method of implantation for use specifically with cylindrical cage devices which are inserted such that the axis of the implant device is perpendicular to the axis of the spine. The reference teaches the use of a series of similarly shaped plugs to be inserted posteriorly between the collapsed bones, for the purposes of separating the adjacent bones, followed by the cutting of the end plates to receive the threaded implant.
The Urbahns, et al. reference (U.S. Pat. No. 6,042,582) teaches the use of intervertebral space measuring tools and a spacer insertion device for facilitating the implantation of an intervertebral spacer (in this reference, the spacer implant is a tubular metal mesh structure which is coaxial with the patient""s spine). The measuring device described in this reference (and shown in FIG. 4) comprises a thin, elongate rod having a fixed cylindrical end having a constant and known thickness. Insertion of this measuring tool into the intervertebral space provides the physician with an approximate understanding of the size of the implant to be inserted. This measurement defines the appropriate cutting of the patient""s bone to create the desired, and necessary, space to receive the metal mesh. The measuring tool is, however, not used to distract the space.
This distraction is provided in conjunction with the spacer insertion instrument shown in FIGS. 13-16. This facilitator, which is more fully described in U.S. Pat. No. 5,431,658 (FIG. 4, thereof), comprises a pair of flat elongate guide surfaces which are hinged at an elbow joint at the distal ends of the surfaces. The distal joint is designed to extend out of the planes defined by the longitudinal axes of the two guides. The proximal ends of the surfaces are to be placed between the collapsed bones. By virtue of the elbow joint, the surfaces are angled substantially when the metal mesh structure, or test member, is placed between the surfaces. The metal mesh (or the test member) is then hammered down the guide surfaces, prying the bodies apart. U.S. Pat. No. 5,431,658, to Moskovich, which was referenced above in the description of the patent to Urbahns, is generally directed to a threaded insertion device for final placement of the femoral ring (not a metal mesh structure) into the intervertebral space. A threaded shaft, having a distal ram portion and an intermediate nut, is coupled to the guide surfaces via stud-groove interfaces that engage studs on the intermediate nut and corresponding grooves on the elongate guide surfaces. The ram portion seats against the femoral ring and causes it to move relative to the guides. The space into which the femoral ring is to be inserted (as above with the metal mesh implant) must be cut to the appropriate size to receive the graft. Initially the surgeon rotateably advances the graft into the space. Subsequent to proper placement of the graft, i.e. when the graft jams into the pre-cut receiving space, continued rotation of the shaft causes the distraction surfaces to be removed by relative motion of the guides to the shaft (the intermediate nut engages the guides and puls them free of the vertebral bones). Failure to properly cut the space, or structural failure of the graft and/or bone material, will prevent removal of the guides, and further rotation of the shaft will drive the allograft further than clinically desired (risking paralysis and/or damage to surrounding vessels).
Referring now to the implant device itself, the substantial drawbacks of cage devices, including, but not limited to: 1. their failure to induce or accept robust ingrowth of bone for the development of a fusion; and 2. their susceptibility to sudden rotational instability, have led to their decreased usage. Correspondingly, the development of various other fusion and non-fusion implant devices has gained momentum. In the interim, however, the use of the classical fusion material, that is femoral ring allograft, has become the standard again. The proper porosity of the allograft bone makes it a superior fusion material, however, simple compression between the adjacent bones (often aided by the tension band of the remaining annulus material) is often not deemed sufficient to prevent dislocation of the implanted ring.
A method of stabilizing the implanted femoral ring allograft, which has gained usage is for the surgeon to insert an interference screw into the endplate of one of the vertebral bones, the extended head of which prevents the femoral ring from translating anteriorly. While effective, this stabilization technique does not entirely prevent movement of the allograft material, and thus does not prevent fusion inhibiting translating events.
It is, therefore, an important feature of the present invention that it provides superior stabilization for use in conjunction with femoral ring allograft material.
It is, however, the main feature of the present invention that it provides a superior fusion promoting implant device that can be completely stabilized in the intervertebral space.
Other featured functionalities of the present invention not explicitly stated will be set forth and will be more clearly understood in conjunction with the descriptions of the preferred embodiments disclosed hereafter.
The present invention comprises a porous metal implant device, shaped to seat in the distracted space between two vertebral bodies, and at least one polyaxial locking screw which maybe inserted through a corresponding hole in the implant, and into the adjacent bone. The polyaxial locking screws are designed to be inserted through the implant and into the bone within a range of angles, but are further designed with a head member that will lock within the hole of the implant. By locking to the implant itself, the screws minimize the possibility of implant or screw translation, and thereby maximize fusion rates.
Alternatively stated, the present invention generally comprises an intervertebral spacer device and locking interference screw assembly which includes a disc-shaped member having a circumferential side surface, and upper and bottom end surfaces. The disc-shaped member includes at least one through hole extending from this side surface through one of said end surfaces. At least one screw is also included, which screw is insertable through the at least one through hole. The head portion of the screw is designed to lock within its corresponding through hole.
The head portion of the screw or screws are encompassed within a hollow interior of a coupling element so that both initially remain selectively rotationally mounted to one another. The coupling element may include a slot that permits the interior volume to open and close around the head of the screw.
In preferred embodiments, the through hole and the coupling element are tapered so that they crush lock together when the coupling element is seated into the through hole.
The disc-shaped member preferably comprises a porous material for permitting bony ingrowth (i.e. promoting fusion across the intervertebral space). It is further anticipated that the upper and bottom end surfaces of the disc-shaped member are to be convex, thus shaping themselves to the end plate bone surfaces of the vertebral bodies.
More particularly with respect to the spacer member itself, the device is formed of a porous material, for example bone allograft material or metal. In the present embodiment, a porous titanium metal mesh, having pore sizes ranging from 100 to 500 microns, is desirable. The shape of the implant, as suggested above, should be ideally formed to fit within the anatomical space provided between the endplates of adjacent vertebral bones. In particular, the upper and lower surfaces should be convex, and the perimeter should be approximately oval. This shape provides for more distributed loading of pressure, which in turn, facilitates bone ingrowth into the matrix of the micromesh.
The implant device is further designed with a series of tapered macroscopic holes which extend from the anterior or lateral face (the side of the implant which, once implanted, is directed toward the front of the spine) through to the upper surface (or alternatively through the lower surface).
The screws of the present invention comprise standard threading and shaft portions. The head, however, is not standard in that it comprises a semi-spherical section. The semi-spherical head of the screw seats within a collet, or coupling member, which is exteriorly tapered and seats in the tapered holes of the implant member. The interior surface of the collet element is correspondingly semi-spherical so that the screw may be implanted polyaxially through the hole, but that the collet will seat in the hole without an angulation relative to the true axis of the hole.
More particularly, the coupling element comprises a socket for holding the ball head of the screw, and an exterior tapered surface which mates with the tapered holes of the plate. In the principle variation, the coupling element includes an axial slot that is forced closed upon insertion into the hole in the plate. Forced closure of the collet, by compression within the tapered hole thereby locks the ball to the coupling element. In another variation, only the lower portion of the collet includes a slot (in this variation, preferably a plurality of slots) for locking the ball head to the coupling element and to the porous spacer implant. In both variations it is preferable for the coupling elements to be tapered so that insertion into the hole locks the ball to the coupling elements.
Specifically, with respect to the method of implantation of this spacer device, the following is a desirable surgical protocol for the insertion and securement of the present invention. After exposing the collapsed disc space, the surgeon removes the damaged cartilage, and distracts the adjacent bones to the desired and proper distance (height), and then inserts the porous spacer of the present invention into the volume that has been created. An insertion tool, which would be ideal for placing the spacer in the proper position, is described more fully in copending application, U.S. Ser. No. 10/076,688, to James D. Ralph and Stephen Tatar, entitled xe2x80x9cFemoral Ring Loaderxe2x80x9d, the specification of which is incorporated herein by reference.
Once the spacer of the present invention is properly positioned, the surgeon inserts the screws through the holes at the desired angle and drives it into the adjacent bone. Complete insertion of the crew causes the coupling member (the collet) to slide into the tapered hole of the spacer and to lock therein, independent of the angulation of the screw (within a range of angles). This secures the spacer implant in the appropriate position. The ability to angulate the screw is a significant advantage. The ability to angulate the screws while simultaneously having the heads of the screws locked to the spacer is the principle advantage of the present invention, which is described in particular preferred embodiments hereinafter, with reference to the included Figures.